Development and validation of RP-HPLC method for combined drug in bulk and its pharmaceutical dosage form.

Abstract

A simple, accurate, precise, and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Nebivolol and Amlodipine in bulk drug and pharmaceutical tablet dosage form. Chromatographic separation was achieved using an Inertsil C18 column (4.6 × 250 mm, 5 µm particle size) with a mobile phase consisting of Acetonitrile and Phosphate Buffer (60:40 v/v, pH 4.0) at a flow rate of 1.0 mL/min. The detection wavelength was selected at 265 nm using a UV detector. The retention time of Amlodipine and Nebivolol was found to be 2.987 min and 5.177 min respectively. The developed method was validated according to ICH guidelines for parameters such as linearity, accuracy, precision, specificity, robustness, ruggedness, limit of detection (LOD), and limit of quantitation (LOQ). The method exhibited excellent linearity within the concentration range of 2–20 µg/mL for both drugs with correlation coefficients greater than 0.999. Recovery studies indicated good accuracy with percentage recovery close to 100%. The proposed method was found to be simple, rapid, reliable, and suitable for routine quantitative analysis of Nebivolol and Amlodipine in combined pharmaceutical dosage forms.